Bard Peripheral Vascular Inc Bard Conquest PTA Balloon dilation Catheter, 6mm x 40mm, 75 cm, Cat. No. CQ7564, UDI: (01) 00801741062902 - Product Usage: use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Dilation catheter packaged with the wrong size balloon. The labeling states that the balloon size is 6mm x 40mm, however included is a 5mm x 40mm balloon. Use of a balloon that has a smaller diameter than expected could result in inconsequential prolongation of an existing procedure.

Recommended Action

Per FDA guidance

On October 1, 2020, the firm mailed consignees a "Urgent Medical Device Recall Notification" via Fed EX that informed consignees about the recall. In addition to informing consignees about the recall, the firm asked consignees to take the following actions: 1. Share this recall notification with all users of the product within your facility to ensure that they are also aware of this recall. 2. Immediately review your inventory for the specific Catalog and lot number listed above. Destroy all product subject to the recall following your institutions process for destruction. 3. Complete the attached Customer Response Form and return to the BD contact noted on the form. Even if you do not have any of the affected lot in your inventory, please complete the Customer Recall Response Form indicating you have zero (0) quantity and return as indicated. 4. Report any adverse health consequences experienced with the use of this product to BD. Events may also be reported to the FDA's MedWatch Adverse Event Reporting program via the following: 5. MedWatch website @ www.fda.gov/medwatch; Phone: 1-800-FDA-1088 (1-800-332-1088) or Mail to MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787